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UNI EN ISO 11979-5 : 2006

UNI EN ISO 11979-5 : 2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY

Superseded date

30-08-2022

Superseded by

UNI EN ISO 11979-5:2021

Published date

01-01-2006

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements applying to biocompatibility
  evaluation of intraocular lenses
5 Physicochemical tests
6 Biological tests
Annex A (normative) Exhaustive extraction test
Annex B (normative) Test for leachables
Annex C (normative) Hydrolytic stability
Annex D (normative) Photostability test
Annex E (normative) Nd-YAG laser exposure test
Annex F (informative) Supplemental conditions of test for
                      local effects after implantation
Annex G (normative) Ocular implantation test
Bibliography

Specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. It also gives guidance on conducting an ocular implantation test.

DevelopmentNote
Supersedes UNI EN 13503-5. (10/2006)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

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